Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Patients with T1b renal tumor and ECOQ\>20

Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols

Renal biopsy

Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols

Cryoablation

Partial nephrectomy will be performed on the basis of the center and according to the current protocols

Partial nephrectomy

Dmitry Enikeev, M.D., Ph.D

Mark Taratkin, MD

The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.

Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor

Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment

Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment

Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life

Renal function will be evaluated with eGFR

Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system

Pain score will be assessed using visual analogue scale

I.M. Sechenov First Moscow State Medical University

Deputy Director for Research

Renal Biopsy

Jaime Landman, MD

The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.

Office-based Percutaneous Ultrasound-guided Renal Biopsy

We do not intend to release individual data to other researchers.

Tumor characteristics will be recorded at Baseline (from preoperative imaging) using the R.E.N.A.L. Nephrometry scoring system which captures tumor radius (R), depth within renal parenchyma (E), nearness to collecting system (N), anterior/posterior location (A) and polarity (L).

Preprocedural and postprocedure verbal analog pain scale. Verbal analog pain scale (0 to 10) will be recorded immediately after and 60 minutes after the procedure. Additional pain assessment will be performed at a follow-up visit 3 days to 3 weeks after the procedure.

University of Michigan

University of California, Los Angeles

Vanderbilt University

University of California, Irvine

Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.

Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

Series I: Radiation will be delivered in 4 fractions.

Series II: Radiation will be delivered in 3 fractions.

stereotactic radiosurgery

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Serum Blood Markers

Mitchell Machtay, MD

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

OBJECTIVES:

Primary

* To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

* To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

* To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Radiosurgery in Treating Patients With Kidney Tumors

Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.

Radiographic efficacy as measured by overall (percent of participants still alive after study completion)

Percent of participants still alive and without tumor progression at study completion

Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)

Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Dose Level I: Radiation will be delivered in 4 fractions:

6 Gy x 4 fractions: Total of 24 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series 1/Dose Level 1: Stereotactic Radiosurgery

Dose Level 2: Radiation will be delivered in 4 fractions:

8 Gy x 4 fractions: Total of 32 Gy

Series 1/Dose Level 2: Stereotactic Radiosurgery

Dose Level 3: Radiation will be delivered in 4 fractions:

10 Gy x 4 fractions: Total of 40 Gy

Series 1/Dose Level 3: Stereotactic Radiosurgery

Dose Level 4: Radiation will be delivered in 4 fractions:

12 Gy x 4 fractions: Total of 48 Gy

Series 1/Dose Level 4: Stereotactic Radiosurgery

Dose Level I: Radiation will be delivered in 3 fractions: 16 Gy X 3 fractions: Total of 48 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series 2/Dose Level 1: Stereotactic Radiosurgery

Dose Level 2: Radiation will be delivered in 3 fractions: 18 Gy X 3 fractions: Total of 54 Gy

Series 2/Dose Level 2: Stereotactic Radiosurgery

Dose Level 3: Radiation will be delivered in 3 fractions: 20 Gy X 3 fractions: Total of 6 Gy

Series 2/Dose Level 3: Stereotactic Radiosurgery

Series I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions total dose of 24 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series I: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions total dose of 32 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series I: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions total dose of 40 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series I: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions total dose of 48 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series II: Radiation will be delivered in 3 fractions: 16 Gy x 3 fractions total dose of 48 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series II: Radiation will be delivered in 3 fractions: 18 Gy x 3 fractions total dose of 54 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series II: Radiation will be delivered in 3 fractions: 20 Gy x 3 fractions total dose of 60 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Mitchell Machtay MD

Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series 1: Stereotactic Radiosurgery

Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Series 2: Stereotactic Radiosurgery

Maximum Tolerated Dose of Radiosurgery

Dose Level I: Radiation will be delivered in 4 fractions:

6 Gy x 4 fractions: Total of 24 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level 2: Radiation will be delivered in 4 fractions:

8 Gy x 4 fractions: Total of 32 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level 3: Radiation will be delivered in 4 fractions:

10 Gy x 4 fractions: Total of 40 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level 4: Radiation will be delivered in 4 fractions:

12 Gy x 4 fractions: Total of 48 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level I: Radiation will be delivered in 3 fractions:

16 Gy X 3 fractions: Total of 48 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level 2: Radiation will be delivered in 3 fractions:

18 Gy x 3 fractions: Total of 54 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Dose Level 3: Radiation will be delivered in 3 fractions:

20 Gy x 3 fractions: Total of 60 Gy

Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of b

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor	NCT04506671	Renal Tumor	Renal biopsy Cryoablation Partial nephrec...	18 Years -	I.M. Sechenov First Moscow State Medical University
Office-based Percutaneous Ultrasound-guided Renal Biopsy	NCT02075684	Renal Cortical ...	Renal Biopsy	18 Years -	University of California, Irvine
Office-based Percutaneous Ultrasound-guided Renal Biopsy	NCT02075684	Renal Cortical ...	Renal Biopsy	18 Years -	University of California, Irvine
Radiosurgery in Treating Patients With Kidney Tumors	NCT00458484	Kidney Cancer	stereotactic ra... Renal Biopsy Serum Blood Mar...	18 Years -	Case Comprehensive Cancer Center

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